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Impact of Continuous Positive Airway Pressure (CPAP) Therapy on Outcomes in Patients Undergoing Coronary Revascularization

Primary Purpose

Obstructive Sleep Apnea, Ischaemic Heart Desease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CPAP

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft, Mortality, Questionnaire, Biomarker

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Angiography confirmed coronary heart disease (CHD) patients
Underwent PCI or coronary artery bypass graft (CABG) in recent the week
Signed informed consent
Mild-to-moderate OSA（5≤AHI≤100)

Exclusion Criteria:

OSA patients who has already started treatment
Patients presenting mainly central apnea (≥ 50%)
Respiratory insufficiency patients

Sites / Locations

Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

no-CPAP

CPAP

Arm Description

CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT02080156

First Posted

February 22, 2014

Last Updated

June 22, 2015

Sponsor

Beijing Anzhen Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02080156

Brief Title

Impact of Continuous Positive Airway Pressure (CPAP) Therapy on Outcomes in Patients Undergoing Coronary Revascularization

Official Title

Impact of Continuous Positive Airway Pressure Therapy on Outcomes in Patients Undergoing Coronary Revascularization

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Investigators assume that continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with obstructive sleep apnea (OSA) patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years.

Detailed Description

Investigators observe whether continuous positive airway pressure (CPAP) therapy can reduce the mortality, stroke rate and secondary coronary surgery in CAD with OSA patients after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABA) during postoperative follow-up of 3 years. During the 3 years, we randomize all enrolled patients to 2 groups separately beginning CPAP or no-CPAP intervention after sleep monitoring. Guidance for all patients during follow-up 1 week, 2 week, 1 month, 3 month. The follow-up procedure includes clinical assessments at three months, six months, one year, two and three years respectively.The primary outcome variables are prospectively being documented and are not subject to observer bias.Baseline comorbidity data, results of the sleep recordings, compliance with CPAP device, scores of the questionnaires as well as results of the blood analysis are performed and/or documented consecutively in separate files by research personnel blinded to the allocation of the study groups and/or unaware of the results of the concomitant outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Ischaemic Heart Desease

Keywords

Obstructive Sleep Apnea, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft, Mortality, Questionnaire, Biomarker

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

no-CPAP

Arm Type

No Intervention

Arm Description

CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

Arm Title

CPAP

Arm Type

Experimental

Arm Description

CPAP vs. no-CPAP in patients undergoing Coronary Revascularization follow-up for 3 years

Intervention Type

Device

Intervention Name(s)

CPAP

Primary Outcome Measure Information:

Title

Mortality

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Angiography confirmed coronary heart disease (CHD) patients Underwent PCI or coronary artery bypass graft (CABG) in recent the week Signed informed consent Mild-to-moderate OSA（5≤AHI≤100) Exclusion Criteria: OSA patients who has already started treatment Patients presenting mainly central apnea (≥ 50%) Respiratory insufficiency patients

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiandao Yuan, MD

Phone

18511821308

yuanxiandao@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hao Wu, MD

Phone

18701617082

wuhao8812@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongxiang Wei, MD PhD

Organizational Affiliation

Capital Medical University Affiliated Beijing Anzhen Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

10029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiandao Yuan, MD

Phone

18511821308

yuanxiandao@126.com

12. IPD Sharing Statement

Learn more about this trial

Impact of Continuous Positive Airway Pressure (CPAP) Therapy on Outcomes in Patients Undergoing Coronary Revascularization

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